What side effects are associated with this type of intervention?

Common treatments for severe asthma, particularly those involving monoclonal antibodies like Depemokimab (Anti-IL-5), often include side effects such as injection site reactions, headache, and increased risk of infections. Combination therapies involving inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) can lead to oral thrush, hoarseness, and potential systemic effects like adrenal suppression. Adding long-acting muscarinic antagonists (LAMA) may cause dry mouth and, less commonly, cardiovascular events. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several Anti-IL-5 monoclonal antibodies for the treatment of asthma, particularly targeting severe eosinophilic asthma. Mepolizumab (Nucala) was approved in 2015, Reslizumab (Cinqair) in 2016, and Benralizumab (Fasenra) in 2017. These drugs work by targeting and inhibiting interleukin-5 (IL-5), a key cytokine involved in the growth, activation, and survival of eosinophils, which are inflammatory cells that play a significant role in asthma. Depemokimab, currently under study, is another Anti-IL-5 monoclonal antibody aimed at providing long-term safety and efficacy for patients with severe eosinophilic asthma.

What other types of research exist?

Promising novel alternatives to Depemokimab for asthma patients in 2024 include Dupilumab (an IL-4/IL-13 inhibitor), Tezepelumab (a thymic stromal lymphopoietin inhibitor), and Benralizumab (an anti-IL-5 receptor monoclonal antibody). These treatments target different inflammatory pathways and have shown efficacy in clinical trials for severe asthma.

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Monoclonal Antibodies

Depemokimab for Severe Asthma (AGILE Trial)

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1), week 26 and week 52

Awards & highlights

Summary

This trial is testing Depemokimab, a medication for people with severe asthma that doesn't respond well to usual treatments. It works by reducing specific cells that cause airway inflammation, aiming to improve breathing and reduce symptoms.

Who is the study for?

This trial is for people with severe asthma who finished previous studies (206713 or 213744) without major health changes. They must be able to consent and follow study rules. In France, they need social security coverage. Those with recent other treatments, helminth infections, cancer during past studies, uncontrolled diseases besides asthma can't join.

What is being tested?

The trial tests the long-term safety and effectiveness of Depemokimab in severe eosinophilic asthma patients over 12 months. It's an extension for those who completed prior related trials and aims to understand how well the drug works over time and its effects on the immune system.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions typical of biologic therapies such as injection site reactions, increased risk of infection, possible allergic responses or issues related to immune system alterations.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had a parasitic infection in the last 6 months or have been treated for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1), week 26 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1), week 26 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 26 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score over 52 weeks (Scores on a scale)

Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 (Scores on a scale)

Change from Baseline in pre-bronchodilator Forced expiratory volume in one second (FEV1) at Week 26 and Week 52 (Liters)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GSK3511294 (Depemokimab)

2021

Completed Phase 3

~800

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments often target the inflammatory pathways involved in the disease. Monoclonal antibodies like Depemokimab (an anti-IL-5 antibody) work by inhibiting IL-5, a cytokine crucial for the growth, activation, and survival of eosinophils, which are inflammatory cells that contribute to asthma symptoms. By reducing eosinophil levels, these treatments help decrease airway inflammation and improve asthma control. This is particularly important for patients with severe eosinophilic asthma, as it can lead to fewer exacerbations and better overall lung function. Other common treatments include inhaled corticosteroids, which reduce inflammation broadly, and bronchodilators, which relax airway muscles to improve breathing.